In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III
- Conditions
- Neurological Diseases
- Interventions
- Device: MRI
- Registration Number
- NCT02455284
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. These tracts form the internal part of the brain and transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for numerous neurological diseases.
Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. Since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. Several validation techniques were previously proposed, none of them being fully convincing in human.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- Prior enrollment in a body donation program
- Age ≥ 82 years
- Absence of major cognitive impairment as demonstrated by independent living skills in 4 fields evaluated by the IADL (4 items) (Lawton and Brody, 1969)
- Distance to one of the participating laboratories ≤ 120km
- Able to remain supine in the MR scanner for acquisition duration (60 min),
- Affiliation to Social Security
- Informed and written consent
Non Inclusion Criteria:
- Past or present Neurological or Neurosurgical diseases (excluding trauma or degenerative spinal lesions)
- Uncontrolled: High blood pressure, diabetes (types I or II), or dyslipemia
- Contraindications to MRI
- Contraindication to body donation
Exclusion criteria
- Diagnosis on MRI of brain lesions, excepted common age-related changes
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy subjects MRI MRI and neuropsychological evaluation
- Primary Outcome Measures
Name Time Method Reconstructions of the fiber tracts 5.5 years similarity indices, such as modified Haussdorf distance, measured on MRI images
- Secondary Outcome Measures
Name Time Method Scores at neuropsychological evaluation 5.5 years Scores at neuropsychological evaluation
Number of subjects included in the database 5.5 years Number of subjects included in the database
In vivo MRI measures obtained from DWI 5.5 years In vivo MRI measures obtained from DWI
Trial Locations
- Locations (7)
University Hospital of Amiens
🇫🇷Amiens, France
University Hospital of Angers
🇫🇷Angers, France
University Hospital of Brest
🇫🇷Brest, France
Hospital of Charpennes - Lyon
🇫🇷Lyon, France
University Hospital of Nancy
🇫🇷Nancy, France
University Hospital of Tours
🇫🇷Tours, France
University Hospital of Rennes
🇫🇷Rennes, France